This is a valid concern, and much discussion is already going on, on how to handle the increase in estrogen which may result. Many of the currently known Propecia side effects relate to the changes in tissue from depletion of DHT, but more often are related to the resulting excess of estrogen caused by the same mechanism. Moral of the story? Further Hair Loss Trials Despite all of this, the results on treating hair loss are impressive. Our contact at Glaxo stated that they will be moving forward on further trials for hair loss, but that it is not yet known when or where they will occur. Glaxo is currently evaluating the designs and types of clinical trials to conduct for hair loss. European Availability Glaxo intends to market the drug in all major European Markets once approvals are finalized in 2003. Dutasteride, like its indirect predecessor Propecia, will not be indicated for use in Women.
It is only a treatment for men. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. For more information, visit www. Teva's Safe Harbor Statement under the U. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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